SEOUL, South Korea, Feb. 25 /PRNewswire/ -- Dong-A PharmTech Co., Ltd. announced today that its European licensee, Dr. Falk Pharma, has initiated a 200 patient, phase 2 proof of concept clinical study to investigate the use of udenafil, a long acting phosphodiesterase type 5 inhibitor, for portal hypertension, an unmet medical need. The multi-center, European study is designed to investigate the safety and efficacy of udenafil in a study population of patients with portal hypertension resulting from liver disease.
Udenafil represents a potential new pharmacotherapy in the growing and underserved portal hypertension market which is projected to be 6 million people (US, EU and Japan) by 2010. Portal hypertension is the build-up of pressure in the portal vein (the vein carrying blood from the spleen and digestive tract to the liver). A major complication related to portal hypertension is variceal bleeding, where increased pressure causes veins in the esophagus to rupture and bleed. These episodes are fatal in 30% of patients and reoccurring in 70% of survivors
The most common cause of portal hypertension is cirrhosis of the liver due to alcohol abuse or hepatitis. Cirrhosis from chronic liver disease ranks among the top 15 causes of death worldwide and is expected to increase over the next 20 years due to the prevalence of hepatitis C and hepatitis B, and an increase in non-alcoholic fatty liver disease in development countries.
An estimated 170 million people are infected with hepatitis C and 350 million with hepatitis B globally. It is estimated that up to 25% of those who are chronically infected with hepatitis will develop portal hypertension due to cirrhosis.
The epidemic of obesity in developed countries will lead to a greater
incidence of non-alcoholic fatty liver disease (NAFLD), Type II diabetes
and high cholesterol which can progress to non-alcoholic steatohepatitis
(NASH) and lead to fibrosis and cirrhosis. It is expected t
|SOURCE Dong-A PharmTech Co., Ltd.|
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